0843

MATERNAL CONTROL - LEVEL 2

(MATERNAL CONTROL 2)
Cat No. MSS5025
Size:
3 x 1 ml

Lot No. 5807MS

Expiry: 2017-10

INTENDED USE
This product is intended for in vitro use in the quality control of Alphafetoprotein, Free Beta hCG, Inhibin A, PAPP-A,
Total Beta hCG and Unconjugated Estriol methods on clinical chemistry systems.
SAFETY PRECAUTIONS AND WARNINGS
Human source material, from which this product has been derived, has been tested at donor level for the Human
Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV)
antibody and found to be NON-REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all
patient samples should be handled as though capable of transmitting disease.
For IN VITRO diagnostic use only.
STORAGE AND STABILITY
OPENED: Store refrigerated (+2C to +8C). Reconstituted serum is stable for 7 days at +2C to +8C if kept capped in
original container and free from contamination. Only the required amount of product should be removed. After use, any
residual product should NOT BE RETURNED to the original vial.
UNOPENED: Store refrigerated (+2C to +8C). Stable to expiration date printed on individual vials.
Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial
contamination is suspected, the vial should be discarded and a fresh vial reconstituted.
PREPARATION FOR USE
Open the vial carefully, avoiding any loss of the material and reconstitute with 1 ml of distilled water. Replace the rubber
stopper, close the vial and leave to stand for 30 minutes before use. Ensure that all traces of dry material are dissolved
by swirling gently.
MATERIALS PROVIDED
Maternal Control - Level 2 3 x 1ml
MATERIALS REQUIRED BUT NOT PROVIDED
Volumetric pipette
VALUE ASSIGNMENT
Each batch of Maternal Control is submitted to a number of external laboratories. Values are assigned from a consensus
of results obtained by these laboratories and internal testing conducted at Randox Laboratories Ltd.
If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or
email Technical.Services@randox.com

29 Jan 15 ne

PAGE 1 OF 3

A
MATERNAL CONTROL - LEVEL 2 (MATERNAL CONTROL 2)
Cat. No. MSS5025

Lot No. 5807MS

Size: 3 x 1 ml

Expiry: 2017-10

Range
Analyte

unit

Target

low

high

methods

Alphafetoprotein

KIU/l = lU/ml

53.5

42.8

64.2

Siemens Immulite 1000

ng/ml

64.7

51.8

77.6

Free Beta hCG

Inhibin A
PAPP-A

KIU/l = lU/ml

53.0

42.4

63.6

ng/ml

64.1

51.3

76.9

KIU/l = lU/ml

51.6

41.3

61.9

ng/ml

62.4

50.0

74.8

KIU/l = lU/ml

52.7

42.2

63.2

ng/ml

63.8

51.1

76.5

KIU/l = lU/ml

57.3

45.8

68.8

ng/ml

69.3

55.4

83.2

KIU/l = lU/ml

49.9

39.9

59.9

ng/ml

60.4

48.3

72.5

KIU/l = lU/ml

48.0

37.2

58.8

ng/ml

58.1

45.0

71.2

KIU/l = lU/ml

53.8

43.0

64.6

ng/ml

65.1

52.0

78.2

KIU/l = lU/ml

56.6

45.3

67.9

ng/ml

68.5

54.8

82.2

KIU/l = lU/ml

40.1

28.1

52.1

ng/ml

48.5

34.0

63.0

Perkin Elmer Delfia/Delfia Xpress/AutoDelfia

Abbott Architect
Siemens Immulite 2000/2500
Siemens Centaur XP/Classic
Beckman DxI800
Brahms Kryptor
Beckman Access
Roche Cobas 6000/8000
Zentech ELISA

KIU/l = lU/ml

58.6

46.9

70.3

ng/ml

70.9

56.7

85.1

mU/mL=U/L

31.5

23.6

39.4

Perkin Elmer Delfia/Delfia Xpress/AutoDelfia

mU/mL=U/L

32.7

24.5

40.9

Siemens Immulite 2000/2500

mU/mL=U/L

28.2

21.2

35.3

Siemens Immulite 1000

mU/mL=U/L

26.4

19.8

33.0

Roche Elecsys 2010/1010

mU/mL=U/L

31.9

23.9

39.9

Brahms Kryptor

mU/mL=U/L

25.2

18.9

31.5

Roche Cobas 6000/8000

mU/mL=U/L

27.1

20.3

33.9

Zentech ELISA

ng/L = pg/ml

234

176

293

Beckman DxI 600/800

ng/L = pg/ml

233

175

291

Beckman Access/LXi725

U/L=mIU/ml

2.37

1.78

2.96

Perkin Elmer Delfia/Delfia Xpress/AutoDelfia

ng/ml

10676

8018

13334

U/L=mIU/ml

9.57

7.18

12.0

ng/ml

43108

32342

53874

U/L=mIU/ml

9.69

7.27

12.1

ng/ml

43649

32748

54550

U/L=mIU/ml

0.260

0.195

0.325

ng/ml

1171

878

1464

U/L=mIU/ml

3.48

2.61

4.35

ng/ml

15676

11757

19595

U/L=mIU/ml

2.42

1.82

3.03

ng/ml

10901

8198

13604

Roche Cobas E411

Siemens Immulite 1000

Siemens Immulite 2000/2500
Beckman DxI 600/800
Roche Elecsys 2010/1010
Brahms Kryptor

___________________________________________________________________________________________________
RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

PAGE 2 OF 3

A
MATERNAL CONTROL - LEVEL 2 (MATERNAL CONTROL 2)
Cat. No. MSS5025

Lot No. 5807MS

Size: 3 x 1 ml

Expiry: 2017-10

Range
Analyte

unit

Target

low

high

methods

PAPP-A

U/L=mIU/ml

3.51

2.63

4.39

Roche Cobas 6000/8000

ng/ml

15811

11847

19775

Total Beta hCG

Unconjugated Estriol

U/L=mIU/ml

3.53

2.65

4.41

ng/ml

15901

11937

19865

mU/ml=IU/l

13236

10589

15883

IU/ml

13.2

10.6

15.9

mU/ml=IU/l

13273

10618

15928
16.0

IU/ml

13.3

10.6

mU/ml=IU/l

22998

18398

27598

IU/ml

23.0

18.4

27.6

mU/ml=IU/l

22871

18297

27445

IU/ml

22.9

18.3

27.5

mU/ml=IU/l

24019

19215

28823

IU/ml

24.0

19.2

28.8

mU/ml=IU/l

13037

10430

15644

IU/ml

13.0

10.4

15.6

mU/ml=IU/l

12854

10283

15425

IU/ml

12.8

10.3

15.3

nmol/L

3.67

2.75

4.59

ng/mL

1.06

0.793

1.33

nmol/L

1.64

1.16

2.12

ng/mL

0.473

0.335

0.610

nmol/L

1.81

1.36

2.26

ng/mL

0.522

0.392

0.652

nmol/L

1.95

1.46

2.44

ng/mL

0.562

0.421

0.703

Roche Cobas E411

Abbott Architect I2000/8200
Siemens Centaur XP/Classic
Perkin Elmer Delfia/Delfia Xpress/AutoDelfia
Siemens Immulite 2000/2500
Siemens Immulite 1000
Beckman DxI 600/800
Roche Cobas 6000/8000
Perkin Elmer Delfia/Delfia Xpress/AutoDelfia
Siemens Immulite 2000/2500
Siemens Immulite 1000
Beckman Access/LXi725

___________________________________________________________________________________________________
RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

PAGE 3 OF 3